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Plant audits are more rigorous and comprehensive than ever before, whether they are executed internally or conducted by a third party. The diversity of audit types—from single-day plant assessments that feel like a check of GMPs to multi-day inspections that take the plumbing, products and people into account—can be confusing, if a food or beverage plant is not prepared.

Industry experts say a more collaborative effort is required for a facility to pass audit evaluations. And knowing what an auditor will look for or the type of questions he or she is likely to ask can help a company prove to current or potential customers that its operations are sound.

World-class internal audits

Risk assessment is a core principle of a comprehensive internal plant auditing system developed in house by H.J. Heinz and implemented in all its plants as a global standard, says Adam Bolain, group leader for process improvement and quality systems at Heinz. Bolain directs the internal audit program for Heinz in North America.

“Identifying potential or actual risk and demonstrating how we are managing that risk assessment make the company more proactive in addressing food safety and food quality issues,” Bolain adds.

At Heinz, a risk assessment delves deeper than regulatory or third-party audits that merely evaluate various operations and procedures and detect nonconformities, says Bolain. For Heinz, knowing the thought processes and rationale behind each activity and the way the activity is performed are significant. “Risk assessment flows out of a mentality similar to continuous improvement. It is a tool that reveals what the highest priorities are,” explains Bolain.

The internal audit program started at a Heinz facility in Europe in 2005 and was introduced to US plants in 2006. “The goal was to develop standards used in every plant that delivered a common and consistent means of managing food safety and product risk. It was developed by a group of quality managers looking to keep the company ahead of more stringent regulations and increasing customer expectations,” says Bolain. Known within the company as the quality risk management process (QRMP), the program utilizes failure modes and effective analysis (FMEA), a risk assessment tool that helps each factory prioritize the risks that need to be addressed.

Conducted on an annual basis, FMEA is used to generate an audit score as part of a corporate audit/assessment and generates a risk priority number (RPN) that is used to reveal areas of risk. Operational standards—such as line performance, control of the line, hygienic design of the equipment, traceability and pest control—and technical standards, including sterilization and pasteurization, are evaluated along with control of records, performance indicators and incident reporting.

FMEA is administered by a cross-functional team comprised of two lead auditors from the Heinz corporate staff, as well as a quality manager from the factory and a food safety manager.

At Heinz, the team members vary each year, so a quality manager, food safety microbiologist or sanitation personnel—many times from a sister plant—are invited to join the audit team, where they can see the best practices firsthand. “They take that knowledge back to their factory and can implement it,” Bolain says.

Heinz requires every plant to be FSSC 22000 certified, which helps minimize audits from customers. The processor’s internal audit program prepares it for the Global Food Safety Initiative (GFSI) benchmark; a high internal audit score is an indication the plant will comply with GFSI. Documentation is organized in a manner that eliminates the preparation of additional documents for GFSI, says Bolain.

Employee training reinforces the philosophy, focus and commitment of the internal auditing program. Training ensures everyone, from the plant manager to a line worker, is familiar with plant standards and understands his or her role in the overall food safety system. Workers are also encouraged to become certified quality auditors through the American Society for Quality.

“QRMP involves every aspect of the manufacturing environment. Training educates and empowers employees to own and manage their part of the process. If there are critical control points in their area, they know what they are and can [respond] when they see a deviation. They become owners of the standard in their area and look for ways to improve the process,” says Bolain.

Heinz assembles different teams, with each unit monitoring performance and adherence on a different part of the process, looking for minor, major and critical nonconformities. “We strive to be audit-ready every day of the week, and that is only possible if each employee is committed to the program. We do not believe there should be a separate activity to get ready for an audit; it should be a way of life and how we conduct business on a daily basis,” states Bolain.

Know the score

Third-party auditors, with some variation based on the program they are following, base a plant’s score on the number and level of nonconformities that impact food safety and quality. Potential plant problems are generally categorized as minor, major and critical nonconformities.

“A pest control device left unchecked is typically deemed a minor offense as it is a singular occurrence or a hiccup in the system; a major offense is one that is a deficiency in the system producing unsatisfactory conditions and is likely to result in a system element breakdown of a program such as pest control or sanitation. A critical nonconformance is issued when there is a breakdown of controls that is judged to cause a significant public health risk, and product safety is compromised such as mislabeling of an allergen on a product, a critical control point not being met, or direct product contamination,” explains LeAnn Chuboff, senior technical director at the Safe Quality Food Institute (SQFI). SQFI is one of several companies that develops the codes auditors use for plant evaluations that are benchmarked to schemes created by GFSI.

SQFI employs a numerical scoring system in which every operation evaluated in the audit begins with a score of 100. One point is deducted for every minor transgression, 10 points for a major nonconformance issue and 50 points if a process breakdown is deemed critical. A score from 100 to 96 is an excellent rating, an audit total from 95 to 86 is good, and a score from 85 to 70 is marked as “comply.” A critical nonconformance results in automatic failure.

“We evaluate management commitment, observe process and production practices at the facility, observe and interview workers, assess the condition of the equipment and the facility, and review documentation and records to determine whether the plant is meeting all the requirements under the program,” Chuboff says.

SQFI offers three auditing levels in its program code. A level one audit targets food safety fundamentals and is intended for those who want to be introduced to an accredited certification program. It is akin to a prerequisite program, providing management with an introduction into oversight. A level two audit addresses broader aspects of food safety, incorporating the principles of the level one audit but adding the evaluation of key system elements, including HACCP principles, management commitment, allergen management and traceability. A level three audit targets food quality components and analyzes operations to determine how and where to improve the procedures to consistently meet customer expectations. Level three uses a novel approach whereby a HACCP method for food safety is applied to food quality. Food safety aspects of the level two and level three audits are benchmarked to the GFSI schemes, according to Chuboff.

SQFI is one of the more active companies developing codes that it submits to GFSI for global certification. The company said last month that it will incorporate an unannounced audit protocol in the next revision of its SQF protocol. The decision is expected to enhance the rigor of the SQFI’s food safety management program and will prepare SQF-certified suppliers to be audit-ready at any time. SQF will become the first internationally accredited third-party assessment program to incorporate mandatory unannounced audits. The audit protocol was introduced last month (February) and will be implemented this July. One out of every three SQF audits will be unannounced once the new protocol is in effect.

The company has 13 programs benchmarked to the GFSI scheme, with new schemes relating to pet food and animal feed recently certified by GFSI (see “What GFSI can do for you,” FE, October 2013).

Audit body viewpoint

Third-party auditors play a vital role in preparing a plant for an audit. Inspectors from these businesses can be retained as consultants to help food and beverage plants select an audit scheme that best fits their operations; tell staff which are the most common issues reviewed or cited in a plant by an auditor; and provide guidance regarding a wide scope of compliance issues, among them process, production, building code, sanitation and documentation. These third-party entities can also be hired for plant audits.

“Several years ago, a major CPG firm presented a paper that compared the different GFSI-certified audit schemes, concluding that each approach tracked along similar lines in terms of requirements, validation and documentation at least 90 percent of the time,” says Richard Stier, a consulting food scientist and auditor with Stratecon International.

However, food plants need to understand the subtle differences between the schemes to avoid the selection of a program that does not ultimately enhance their operations. The difference can come down to the method of implementation, recordkeeping, qualifying or evaluation.

“Certain auditing schemes are prescriptive in nature and demand that all procedures be followed exactly. Otherwise, the food plant won’t pass that element of an audit,” says Stier. He cites a manufacturer of milk in aseptic packaging, where management might not worry about the type of clothing worn by line personnel at the processing and packing stage of the line because it is a closed system.

“An auditor may consider any ‘infraction’ a nonconformity and take a deduction because the audit scheme stipulates it, even though workers’ clothing isn’t critical at that point of the process, and the plant can prove it with documentation. With another scheme, this observation might not result in a penalty,” says Stier.

Stier says the physical condition of the plant itself tends to be the area where problems can arise. This is because many food processors operate in plants built decades ago, and are constructed of materials and feature designs (e.g., overhead structures) facilities would not use today. The natural environment can also be important. “I knew a processor who had a major problem with fruit flies, so he scheduled his audit visits for the winter months,” Stier recalls.

Unlike FDA or USDA inspectors, third-party consultants can be flexible. For example, if a third-party consultant discovers a critical control point was missed—say a metal detector was turned off for an entire shift—the company may have the option to change the review from a certifying audit to a consulting audit so the plant does not fail.

The consultant can conclude the assessment in an advisory role and perhaps provide recommendations. Stier says this flexibility is something that could end if FDA is able to implement new regulations requiring auditors to notify it if they observe a problem that is critical and represents an imminent food safety issue.

Context is a core competency for auditors, says Robert Thrash, president of Process Management Consulting. “Auditors must have deep knowledge regarding the industry they are working in. But even that may not be enough for a perfect evaluation because variations in process and product exist from plant to plant. Auditing is about fact-finding, so the plant has to show how it is being managed,” he states.

Thrash says determining whether a program is ineffective is not a cut-and-dry matter. “If you have a cooling or refrigerated area and you find it is not down to temperature, does that mean the process is ineffective? The plant should ascertain whether the food is being exposed to a safety risk. If so, then you have to find out how long the problem has existed and what the plan is to correct it.”

If a line operator discovers product is out of specification, and it occurred between two quality control checks, Thrash says, an auditor wants to know how you establish when to start pulling product that might be impacted and when you stop. “Suppose an auditor asks you to perform a mock recall. Does everyone know his or her role? What steps are taken, and how efficiently is it done?”

Thrash says when good audit preparedness and GMP come together, it brings a boost to food safety awareness. For example, Process Management conducted annual food safety audits for a Pennsylvania-based cookie maker for some time. Each year, the company, with a staff of 10, corrected any discovered issue. When the auditor would find another issue the following year, the same thing would happen. The continuous audits pushed the company to higher levels of efficiency. Finally, the owner asked Process Management to assess the plant as a BRC-certified auditor. “The owner said that five years ago, the company could never have undertaken such an audit, but now customers are requesting it, and the company can keep them because it can achieve it,” Thrash explains.

Small to medium-sized businesses are getting more involved with auditing to grow market share. Minh Phu Corp., a Vietnam-based seafood company, wanted to become a trusted supplier due to rising worldwide demand. The company, established as a family business in 1992, paid keen attention to its labor force and quality management systems, recognizing the key to success in Asia and abroad depended on monitoring the entire supply chain from sourcing to the end-user.

When the aquaculture-focused business transitioned from a family company to a share-holding entity in 2006, it adopted several key global standards, including GMP, SSOP, HACCP, ISO 2000, ISO 2005, ACC and BRC. However, to take what it called a valuable next step in assuring consumer and retailer trust in its brand, the company sought and achieved GlobalGap certification.

Minh Phu selected Intertek for assistance with GlobalGap’s standards, which are currently adopted in more than 100 countries. “We believe this [achievement] opens doors to our growth and recognition as a quality seafood provider,” says Tan Ngoan, quality manager.

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